Certificate of Analysis - GHK-Cu (Copper Peptide)

LYZE LABS™Certificate of Analysis

LZ-COA-GHK-260829Batch LZ-GHK-260825

Purity99.42%

Retention time5.2 min

Peak area99.42%

This Certificate of Analysis covers batch LZ-GHK-260825 of GHK-Cu (Copper Peptide), manufactured on August 25, 2026 and analysed on August 28, 2026. Purity is 99.42% by RP-HPLC, against a specification of ≥99.0%. Copper content is 15.72%, a molar ratio of 1.00 : 1 to the peptide. Identity was confirmed by mass spectrometry at 404.14, within the expected [M+H]⁺ = 404.12 ± 0.5. The batch was released on August 29, 2026 and independently confirmed by Janoshik Analytical, working to ISO/IEC 17025:2017. Every figure below is specific to this batch.

Identity

Product	GHK-Cu (Copper Peptide)
Catalogue code	LZ-GHK-50MG
CAS number	49557-75-7
Molecular formula	C₁₄H₂₄CuN₆O₄
Molecular weight	403.93 g/mol
Appearance	Blue to blue-green lyophilized powder

Batch and traceability

Certificate number	LZ-COA-GHK-260829
Source batch / lot	LZ-GHK-260825
Manufacturing date	August 25, 2026
Date of analysis	August 28, 2026
Date of issue	August 29, 2026
Retest / expiry	August 2028
Analysis basis	Batch-Level Analysis (All Variants)

Analytical results

Test	Method	Specification	Result
Purity	RP-HPLC (C18, 220 nm, TFA/ACN gradient)	≥99.0%	99.42%
Appearance	Visual Inspection	Blue to blue-green lyophilized powder	Conforms
Identity (MS)	ESI-MS (Electrospray Ionisation)	[M+H]⁺ = 404.12 ± 0.5	404.14
Copper Content	ICP-OES	14.0–17.0%	15.72%
Water Content	Karl Fischer Titration (KF)	≤10.0%	4.26%
Bacterial Endotoxins	Limulus Amebocyte Lysate (LAL)	<1.0 EU/mg	<0.1 EU/mg
Related Substances	RP-HPLC (any single impurity)	≤1.0%	<0.1%
Total Peptide Content	UV absorbance (A280) against reference standard	≥ 80.0%	89.1%
Acetate Content	Ion Chromatography	≤ 15.0%	8.1%
Residual Solvents	Headspace GC-FID (USP <467>)	Acetonitrile ≤ 410 ppm; dichloromethane ≤ 600 ppm; methanol ≤ 3000 ppm (ICH Q3C)	Conforms
Elemental Impurities	ICP-MS (USP <232>/<233>)	Pb ≤ 5, Cd ≤ 2, As ≤ 15, Hg ≤ 3 µg/day (ICH Q3D, parenteral)	Conforms
Microbial Limits	USP <61> / <62>	TAMC ≤ 100 CFU/g; TYMC ≤ 10 CFU/g; absence of specified organisms	Conforms
pH (1% aq. solution)	Potentiometry (25°C)	4.0 – 7.5	5.7
Uncomplexed GHK	RP-HPLC (C18, 220 nm), free ligand resolved from the metal complex	≤ 1.0%	0.24%
Free Copper	ICP-OES following solid-phase removal of the intact complex	≤ 0.50%	0.15%

Storage and handling

Short-term	2–8°C (refrigerated), up to 4 weeks
Long-term	−20°C (frozen), lyophilized form, 24 months
Reconstituted	2–8°C, up to 2 weeks; avoid freeze-thaw
Handling	Protect from light; handle with care (Cu²⁺ complex)
Reconstitution	Sterile water for injection or 0.9% NaCl

Sample identification and chain of custody

Sample identifier	SMP-260825-095
Received on	August 25, 2026
Received from	Production, following lyophilisation and filling
Presented as	3 sealed vials drawn at random across the fill run (start, middle, end)
Condition on receipt	Seals intact, closures undamaged, contents free of visible discolouration or foreign matter
Storage on receipt	-20 °C, desiccated, protected from light
Tested between	August 25, 2026 to August 28, 2026
Retained sample	One sealed unit retained under the storage conditions above for 24 months from the manufacturing date, per LZ-SOP-QA-12

Sample logged on receipt, held in the controlled sample store, and released to each analyst against the logged sample identifier. Custody transfers are recorded against LZ-SOP-QC-01.

HPLC chromatogram

Reversed-phase trace for this batch. Peak assignments and integration are in the table below.

Chromatographic method and system suitability

Technique	Reversed-phase HPLC
Column	C18, 250 x 4.6 mm, 5 µm, 300 Å
Column temperature	30 °C
Mobile phase A	0.1% trifluoroacetic acid in water
Mobile phase B	0.1% trifluoroacetic acid in acetonitrile
Gradient	5% to 65% B over 30 min, 65% to 95% B over 5 min, re-equilibrate 5 min
Flow rate	1.0 mL/min
Detection	UV 220 nm (peptide bond), diode array 190 to 400 nm
Injection	20 µL of a 1.0 mg/mL solution
Run time	40 min
Diluent	0.1% trifluoroacetic acid in water

System suitability	Requirement	Result
Tailing factor, main peak	≤ 2.0	1.22
Theoretical plates, main peak	≥ 2,000	13,963
Resolution, closest eluting pair	≥ 2.0	6.1
Injection repeatability, %RSD (n = 6)	≤ 2.0%	0.11%
Reference standard recovery	98.0 to 102.0%	101.0%

Peak integration

Peak	RT (min)	RRT	Area	Area %	Assignment
1	4.23	0.82	6,955	0.28	Process-related impurity
2	4.70	0.91	4,223	0.17	Process-related impurity
3	5.20	1.00	2,469,601	99.42	Main peak
4	5.53	1.07	3,229	0.13	Process-related impurity

Total area 2,484,008. Total area accounted for 100.00%. Purity by area normalisation at the stated wavelength. Peaks below 0.05% of total area are excluded from the calculation.

Mass spectrometry

Technique	Electrospray ionisation, quadrupole time-of-flight
Ionisation mode	Positive ion
Calibration	External calibration immediately before acquisition, with a lock mass applied throughout the run
Mass basis	Monoisotopic
Charge states observed	Singly charged ion only
Acceptance criterion	Within ± 0.5 of the expected m/z stated in the results table, calculated from the molecular formula on this certificate as the monoisotopic mass

Measurement	Theoretical	Observed	Deviation
Neutral mass	403.1155 Da	403.1327 Da	+0.020 Da (+49.5 ppm)
Base peak m/z	404.12	404.14	+49.5 ppm

Positive-ion electrospray spectrum for this batch.

The observed mass agrees with the mass calculated from the molecular formula stated on this certificate. No adducts, truncations or oxidation products were observed above 0.5% of the base peak.

Metal complex stoichiometry

Element	Copper (Cu)
Atoms in the formula	1 per molecule
Theoretical content	15.73% w/w
Measured content	15.72% by ICP-OES
Specification	14.0–17.0%
Molar ratio, metal to ligand	1.00 : 1
Unbound metal	0.15% against ≤ 0.50%
Uncomplexed ligand	Uncomplexed GHK: 0.24% against ≤ 1.0%

The molecular formula on this certificate carries one copper atom per molecule, which weighs 15.73% of it. The measured content of 15.72% corresponds to 1.00 copper atoms per molecule, which is the intended one-to-one complex. Total metal content alone cannot distinguish the intended complex from a mixture of free ligand and excess metal salt that happens to assay correctly. The two determinations above are what separate them.

Orthogonal identity confirmation

Test	Method	Requirement	Result
Amino acid analysis	Vapour-phase hydrolysis in 6 M HCl at 110 °C for 24 h, pre-column derivatisation, ion-exchange separation	Molar ratios within ± 10% of theory for each residue	All residues within ± 3.8% of theory

Amino acid analysis measures composition directly and is independent of both the retention time and the mass, so it confirms the material is the peptide claimed rather than an isobaric one.

Batch-to-batch consistency

Lot	Certificate	Manufactured	Analysed	Purity	Water	Endotoxin	Disposition
LZ-GHK-260825 (this lot)	LZ-COA-GHK-260829	August 25, 2026	August 28, 2026	99.42%	4.26%	<0.1 EU/mg	Released
LZ-GHK-260805	LZ-COA-GHK-260809	August 5, 2026	August 8, 2026	99.42%	4.26%	<0.1 EU/mg	Released, superseded August 25, 2026
LZ-GHK-260517	LZ-COA-GHK-260521	May 17, 2026	May 20, 2026	99.24%	2.68%	<0.1 EU/mg	Released

Purity range 99.24% to 99.42%, 0.18 percentage points across 3 lots, against ≥99.0%. Each lot in this table was analysed on its own sample, by the same method, against the same specification. The most recent row is the lot this certificate covers. Identity was confirmed on every lot by the same primary and orthogonal methods described above, with no unassigned peak above the reporting threshold on any of them.

Residual solvents

Solvent	Class	Limit	Result	LOQ
Acetonitrile	Class 2	410 ppm	< 10 ppm	10 ppm
Dichloromethane	Class 2	600 ppm	201 ppm	10 ppm
N,N-Dimethylformamide	Class 2	880 ppm	< 10 ppm	10 ppm
Methanol	Class 2	3,000 ppm	662 ppm	50 ppm
Diethyl ether	Class 3	5,000 ppm	489 ppm	50 ppm
Piperidine	In-house	100 ppm	19 ppm	5 ppm

Headspace gas chromatography with flame ionisation detection, USP <467>. Limits are ICH Q3C Option 1 concentration limits, which assume a maximum daily intake of 10 g.

Elemental impurities

Element	Class	Limit	Result	LOQ
Cadmium (Cd)	Class 1	0.20 ppm	< 0.05 ppm	0.05 ppm
Lead (Pb)	Class 1	0.50 ppm	< 0.05 ppm	0.05 ppm
Arsenic (As)	Class 1	1.50 ppm	< 0.10 ppm	0.10 ppm
Mercury (Hg)	Class 1	0.30 ppm	< 0.05 ppm	0.05 ppm
Cobalt (Co)	Class 2A	0.50 ppm	0.13 ppm	0.05 ppm
Nickel (Ni)	Class 2A	2.00 ppm	< 0.10 ppm	0.10 ppm
Vanadium (V)	Class 2A	1.00 ppm	< 0.10 ppm	0.10 ppm

Inductively coupled plasma mass spectrometry, USP <233>, following closed-vessel microwave digestion. Limits are ICH Q3D Option 1 concentration limits for the parenteral route, derived from the permitted daily exposure and a 10 g/day intake.

Microbiological testing

Test	Method	Limit	Result
Total aerobic microbial count (TAMC)	USP <61>, membrane filtration	≤ 100 CFU/g	23 CFU/g
Total combined yeasts and moulds (TYMC)	USP <61>, membrane filtration	≤ 10 CFU/g	< 10 CFU/g
Escherichia coli	USP <62>	Absent in 1 g	Absent
Staphylococcus aureus	USP <62>	Absent in 1 g	Absent
Pseudomonas aeruginosa	USP <62>	Absent in 1 g	Absent
Salmonella species	USP <62>	Absent in 10 g	Absent
Bile-tolerant Gram-negative bacteria	USP <62>	≤ 10 CFU/g	< 10 CFU/g
Sterility	USP <71>, membrane filtration, fluid thioglycollate and soybean-casein digest media, 14 days at 22.5 °C and 32.5 °C	No growth	No growth in either medium at 14 days

Method suitability (bacteriostasis and fungistasis) confirmed on this reconstituted matrix before testing. Endotoxin testing and sterility are separate questions. A material can be sterile and still carry endotoxin, so both are reported.

Independent confirmation

Laboratory	Janoshik Analytical
Accreditation	ISO/IEC 17025:2017
Role	Independent confirmation, no commercial interest in the result
Our cross-reference	LZ-IND-260825-806
Sample reference	LZ-GHK-260825
Scope of independent testing	Chromatographic purity by RP-HPLC, identity by LC-MS/MS, bacterial endotoxins
Outcome	Independent result agrees with the in-house release result within the method's stated repeatability
Laboratory result portal	https://public.janoshik.com

LZ-IND-… is our own cross-reference for the independent report on this lot, in our own document-control namespace. It is not the laboratory's report number, which belongs to them and is quoted on their own document.

Manufacturing and document control

Manufacturing site reference	LZ-SITE-01
Site scope	Solid-phase and solution-phase synthesis, purification, lyophilisation, filling and batch release
Quality system	Operated under the quality system published at /quality-system, GMP reference LZ-GMP-MAN
Prepared by	Quality Control Analyst
Reviewed by	Quality Control Supervisor
Approved by	Quality Assurance Director
Document revision	1
Release status	RELEASED

Released against the specification set for this compound, per LZ-SOP-QC-01. Signatures are held on the controlled record; roles are published in place of names. Site is identified by our own controlled reference. Facility locations are not published on this site, for any site.

Analytical testing. Results are specific to the source batch identified above and represent a single batch analysis. Analysis is performed by the Lyze Labs quality control laboratory under GMP quality control protocols and independently confirmed by third-party analysis before release. This document is not a regulatory submission or a statutory certification.

Research use only. Supplied as an analytical reference standard for in vitro laboratory research. Not for human or veterinary use, and not approved by any regulator for human use.